A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin

This study is ongoing, but not recruiting participants.

First Received: November 24, 2004 Last Updated: January 27, 2010 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00097539

Purpose

This study is a multicenter, open label, observational, postmarketing surveillance study of Nutropin AQ, Nutropin, and Protropin in the United States and Canada. This study (and subsequent substudies) were developed to investigate specific aspects of growth hormone (GH) treatment.

Condition	Phase
Growth Disorders	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Genentech National Cooperative Growth Study (NCGS) Postmarketing Surveillance Program for Nutropin AQ [Somatropin (rDNA Origin) Injection], Nutropin [Somatropin (rDNA Origin) for Injection], and Protropin [Somatrem for Injection]

Resource links provided by NLM:

MedlinePlus related topics: Growth Disorders

Drug Information available for: Somatropin Somatrem Somatotropin

U.S. FDA Resources

Further study details as provided by Genentech:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	58998
Study Start Date:	October 1985
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic

Criteria

Inclusion Criteria:

Children of either sex who are treated with Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure
Subjects who are willing to keep follow up appointments throughout study participation

Exclusion Criteria:

Subjects treated with a non-Genentech GH preparation
Subjects with closed epiphyses
Subjects with active neoplasia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097539

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Barbara Lippe, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	85-036
Study First Received:	November 24, 2004
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00097539 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

Pediatric growth disorders

Additional relevant MeSH terms:

Pathologic Processes
Disease
Growth Disorders

ClinicalTrials.gov processed this record on February 08, 2010